TriangleNCT00064077 · OUTCOME
Frequency of Response Using RECIST Version 1.0
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)
What was measured
RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above.
Analysis population: Evaluable (treatment)
Groups in this outcome
Arm I (Paclitaxel, Cisplatin)
Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
Arm II (Vinorelbine, Cisplatin)
Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV
Arm III (Gemcitabine, Cisplatin)
Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies
Arm IV (Topotecan, Cisplatin)
Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV
| Group | Source count |
|---|---|
| Arm I (Paclitaxel, Cisplatin) | 103 |
| Arm II (Vinorelbine, Cisplatin) | 108 |
| Arm III (Gemcitabine, Cisplatin) | 112 |
| Arm IV (Topotecan, Cisplatin) | 111 |
Reported measurements
Source class 1
Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Paclitaxel, Cisplatin) | 3 | Not reported | Not reported | Not reported | Not reported |
| Arm II (Vinorelbine, Cisplatin) | 8 | Not reported | Not reported | Not reported | Not reported |
| Arm III (Gemcitabine, Cisplatin) | 1 | Not reported | Not reported | Not reported | Not reported |
| Arm IV (Topotecan, Cisplatin) | 2 | Not reported | Not reported | Not reported | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Paclitaxel, Cisplatin) | 27 | Not reported | Not reported | Not reported | Not reported |
| Arm II (Vinorelbine, Cisplatin) | 20 | Not reported | Not reported | Not reported | Not reported |
| Arm III (Gemcitabine, Cisplatin) | 24 | Not reported | Not reported | Not reported | Not reported |
| Arm IV (Topotecan, Cisplatin) | 24 | Not reported | Not reported | Not reported | Not reported |
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Paclitaxel, Cisplatin) | 50 | Not reported | Not reported | Not reported | Not reported |
| Arm II (Vinorelbine, Cisplatin) | 46 | Not reported | Not reported | Not reported | Not reported |
| Arm III (Gemcitabine, Cisplatin) | 54 | Not reported | Not reported | Not reported | Not reported |
| Arm IV (Topotecan, Cisplatin) | 53 | Not reported | Not reported | Not reported | Not reported |
Progressive Disease/other
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Paclitaxel, Cisplatin) | 23 | Not reported | Not reported | Not reported | Not reported |
| Arm II (Vinorelbine, Cisplatin) | 34 | Not reported | Not reported | Not reported | Not reported |
| Arm III (Gemcitabine, Cisplatin) | 33 | Not reported | Not reported | Not reported | Not reported |
| Arm IV (Topotecan, Cisplatin) | 32 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- title
- Complete Response
- measurements
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 20
- group Id
- OG002
- value
- 24
- group Id
- OG003
- value
- 24
- title
- Partial Response
- measurements
- group Id
- OG000
- value
- 50
- group Id
- OG001
- value
- 46
- group Id
- OG002
- value
- 54
- group Id
- OG003
- value
- 53
- title
- Stable Disease
- measurements
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 34
- group Id
- OG002
- value
- 33
- group Id
- OG003
- value
- 32
- title
- Progressive Disease/other
- denoms
- counts
- group Id
- OG000
- value
- 103
- group Id
- OG001
- value
- 108
- group Id
- OG002
- value
- 112
- group Id
- OG003
- value
- 111
- units
- Participants
- description
- RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above.
- groups
- description
- Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
- id
- OG000
- title
- Arm I (Paclitaxel, Cisplatin)
- description
- Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV
- id
- OG001
- title
- Arm II (Vinorelbine, Cisplatin)
- description
- Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies
- id
- OG002
- title
- Arm III (Gemcitabine, Cisplatin)
- description
- Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV
- id
- OG003
- title
- Arm IV (Topotecan, Cisplatin)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Evaluable (treatment)
- reporting Status
- POSTED
- time Frame
- Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)
- title
- Frequency of Response Using RECIST Version 1.0
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice